Cleared Traditional

K112795 - PALTOP DENTAL IMPLANT SYSTEM

K112795 is an FDA 510(k) clearance for PALTOP DENTAL IMPLANT SYSTEM, manufactured by Paltop Advanced Dental Solutions, Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K112795 · Paltop Advanced Dental Solutions, Ltd. · Dental device
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Apr 2012
Decision
207d
Days
Class 2
Risk

K112795 is an FDA 510(k) clearance for the PALTOP DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Paltop Advanced Dental Solutions, Ltd. (Caesarea, IL). The FDA issued a Cleared decision on April 20, 2012 after a review of 207 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Paltop Advanced Dental Solutions, Ltd. devices

FDA 510(k) Submission Details - K112795

510(k) Number K112795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2011
Decision Date April 20, 2012
Days to Decision 207 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 128d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 1370
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